BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PULSE-GENERATOR, DUAL CHAMBER, IMPLANTABLE

    MDR report key: 3862687 · Received June 10, 2014

    Report

    Report Number
    2183613-2014-00871
    Event Type
    Malfunction
    Date Received
    June 10, 2014
    Date of Event
    April 10, 2014
    Report Date
    April 29, 2014
    Manufacturer
    MEDTRONIC MILACA, INC.
    Product Code
    LWP
    PMA / PMN Number
    P820003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IS BASED SOLELY ON DEVICE ANALYSIS. NO INFORMATION TO SUGGEST A DEVICE RELATED ADVERSE EVENT OR PRODUCT PROBLEM WAS RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. PRODUCT EVENT SUMMARY: ANALYSIS CONFIRMED THE CUSTOMER COMMENT THAT THE LIQUID CRYSTAL DISPLAY LENS WAS BROKEN. ANALYSIS ALSO FOUND THAT THE UPPER AND LOWER CASES, ONE SIDE BAIL COVER, THE RING COVER AND THE BATTERY DRAWER WERE BROKEN, AND THAT THE LEAD FLEX COVER WAS CONTAMINATED. IT WAS NOTED THAT THE CABLE RETURNED WITH THE GENERATOR PASSED CONTINUITY AND VISUAL INSPECTION. (B)(4).

    Description of Event or Problem · 1

    THE EXTERNAL PULSE GENERATOR WHICH WAS RETURNED AS A RESULT OF BEING DROPPED SUBSEQUENTLY TESTED OUT OF SPECIFICATION DURING MANUFACTURER'S ANALYSIS. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    338959 PULSE-GENERATOR, DUAL CHAMBER, IMPLANTABLE LWP MEDTRONIC MILACA, INC. 5388

    Patients

    Seq Age Sex Outcome Treatment
    1